The Benefits of Home Exercise in Pulmonary Hypertension Interstitial Lung Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester

About this trial

This study evaluates the effects of a structured home exercise program in participants with pulmonary hypertension associated with interstitial lung disease. Participants will complete a defined exercise regimen over a 16-week period, and functional capacity and patient reported outcomes will be assessed at baseline and after the intervention. The study aims to determine whether a home-based exercise approach is feasible and associated with improvements in functional performance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Follows at University of Rochester Medical Center Pulmonary Hypertension Clinic.

Adult patients (>18 years old) with right heart catheterization confirmed pulmonary hypertension interstitial lung disease on stable therapy dosing for at least 30 days.

Access to a smart phone or email to receive daily messages.

Clinically stable by the investigator.

Disqualifiers

Pregnancy.

Pulmonary Hypertension Groups 1,2,4,5.

Resting tachycardia >120 beats/m during screening.

Inability to walk.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Home Exercise Program, Aerobic Plus Strength Training

    Behavioral

    Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic and strength training activities with heart rate guidance.

  • Home Exercise Program, Aerobic Only

    Behavioral

    Structured home based exercise program delivered by daily SMS text message or email for 16 weeks, including aerobic activities with heart rate guidance.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Aerobic Plus Strength TrainingExperimental treatment 1 intervention
Group B: Aerobic onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change in Cardiac Effort From Baseline to 16 Weeks

Cardiac Effort is measured as the ratio of the total number of heart beats recorded during the Six Minute Walk Test to the total distance walked in meters. Heart rate is continuously monitored during the test using a validated heart rate monitoring device. The value represents the number of heart beats required per unit distance walked (beats per meter). Individual participant values are calculated at baseline and at 16 weeks. The outcome is defined as the mean change in Cardiac Effort from baseline to 16 weeks across participants. Lower values indicate improved cardiac efficiency and better functional performance, while higher values indicate reduced efficiency and worse functional status.

Time frame
Baseline to 16 weeks

Secondary outcomes

1

Mean Change in Six Minute Walk Distance From Baseline to 16 Weeks

Six Minute Walk Distance is measured using the standardized Six Minute Walk Test according to established clinical guidelines. The total distance walked in meters during six minutes is recorded for each participant. Individual participant values are collected at baseline and at 16 weeks. The outcome is defined as the mean change in distance walked from baseline to 16 weeks across participants. Higher values indicate improved functional capacity, while lower values indicate reduced exercise tolerance.

Time frame
Baseline to 16 weeks
2

Mean Change in emPHasis-10 Score From Baseline to 16 Weeks

Quality of life is measured using the emPHasis-10 questionnaire, a validated patient reported outcome instrument specific to pulmonary hypertension. The questionnaire consists of 10 items assessing symptoms and impact on daily life. Scores range from 0 to 50, with higher scores indicating worse health related quality of life. Individual participant scores are calculated by summing item responses. The outcome is defined as the mean change in total score from baseline to 16 weeks across participants.

Time frame
Baseline to 16 weeks post intervention
3

Mean Change in King's Brief Interstitial Lung Disease Questionnaire Score From Baseline to 16 Weeks

Quality of life is measured using the King's Brief Interstitial Lung Disease questionnaire, a validated instrument assessing health status in interstitial lung disease. Scores range from 0 to 100, with higher scores indicating better health status. Individual participant scores are calculated according to standard scoring procedures. The outcome is defined as the mean change in score from baseline to 16 weeks across participants.

Time frame
Baseline to 16 weeks
4

Mean Change in Lower Extremity Muscle Strength From Baseline to 16 Weeks

Muscle strength is measured using a Lafayette Muscle Dynamometer for quadriceps strength and a Jamar Hand Dynamometer for hand grip strength. Measurements are recorded in pounds (lbs) for each participant. Individual participant values are obtained at baseline and at 16 weeks. The outcome is defined as the mean change in muscle strength from baseline to 16 weeks across participants. Higher values indicate greater muscle strength, while lower values indicate reduced strength.

Time frame
Baseline to 16 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Rochester

Lead sponsor

Liquidia Technologies, Inc.

Collaborator

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